AKI (Acute Kidney Injury) Due to TraumaPhase 4Dye-Vert PlusNCT04279457
Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System
A Phase 4 study testing DyeVert Plus System and Standardized hydration protocol in people with AKI (Acute Kidney Injury) Due to Trauma, run by CAMC Health System at 1 site in United States.
Trial summary
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures which require the use of intravenous contrast media. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- AKI (Acute Kidney Injury) Due to Trauma
- What is being tested?
- DyeVert Plus System and Standardized hydration protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,802 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 3 Feb 2022
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Scheduled to undergo CAG and/or PCI
- Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
- Serum creatinine > 1.5mg/dl
- Obtaining a Cardiac catheterization.
- HTN/Diabetes
- Inpatient and outpatient
Who cannot join
- 91 years of age or older
- Serum creatinine < 1.5mg/dl
- eGFR > 60ml/min
- Pregnancy
- Dialysis
- Dye Allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CAMC Health Education and Research Institute
Charleston, West Virginia, 25304
About this study
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures which require the use of intravenous contrast media. The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar contrast media, repeated exposure to contrast within 48 hours, volume of contrast used). Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of low-osmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. The DyeVert plus Contrast Reduction System, is designed to lower the amount of contrast dye the kidneys are exposed to during a procedure. Because the amount of contrast dye is precisely controlled. The purpose of this prospective study is to understand how the monitoring system of Dye-Vert Plus will impact Acute Kidney Injuries rates in high-risk patients undergoing cardiac catheterization when used in conjunction with a standardized hydration policy.
Read the detailed description
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures associated with Contrast-induced nephropathy (CIN). The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%1. The development of CIN after diagnostic coronary angiography and/or percutaneous coronary intervention (PCI) is associated with prolonged hospitalization and a remarkable increase in morbidity, early and late mortality and costs. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar CM, repeated exposure to contrast within 48 h, volume of contrast used, etc.)2-5. Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of lowosmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. Patients that have a serum creatinine of > 1.5mg/dl and an eGFR < 60ml/min might be at higher risk for AKIs. In quarter one of 2018, CAMC's in-hospital risk-adjusted acute kidney injury for patients undergoing PCI was 10.64, and the US 50th percentile was 6.476. The goal of this study is to reduce in-hospital risk-adjusted acute kidney injury for patients undergoing PCI, below the US 50th, percentile-based NCDR quarterly results of the Cath-PCI registry by quarter one of 2020.
CIN is one of the leading causes of acute kidney injury at Charleston Area Medical Center it is imperative to take steps to prevent it. CIN is associated with a 13% increase in one- year mortality rate when comparing patients without CIN. Studies have also shown an increase in inpatient length of stay and substantial increase cost for patients who experienced CIN. The economic burden associated with CIN is high, the average in-hospital cost of CIN is $10,345 7. Adopting targeted interventions will reduce the incidence of CIN and the overall economic burden at Charleston Area Medical Center.
This trial is aimed at observing whether the use of the monitoring system Dye-Vert PLUS in conjugation with implementing a pre-hydration protocol on patients with high risk for CIN admitted for cardiac angiography and/or interventional cath lab procedures may reduce the incidence of CIN. An additional aim of the study will be to assess if use of the Dye-Vert PLUS monitoring system reduces the use of mean contrast media given in high-risk patients. Additional aims of this initiative will be to evaluate contrast-related complications, such as hypersensitivity reactions, as well as the associated impact of contrast-related complications on hospital health 3 care economics. This initiative will strive to incorporate clinical practice guidelines from SCAI Expert Consensus Statement: 2016 Best Practices in the Cardiac Catheterization Laboratory related to patient risk screening, pre-procedure hydration, and minimizing contrast media dose used.
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Being tested
- DyeVert Plus System, Standardized hydration protocol
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DyeVert Plus SystemDevice
The DyeVert Plus System also contains a reusable Contrast Monitoring Wireless Display (CMW) which communicates with the Dye-Vert Plus Disposable to allow real-time monitoring and display of contrast volumes manually injected compared to a predefined, physician-entered contrast usage threshold throughout the procedure. At the end of the procedure, the CMW displays total procedure contrast volume used (mL), % of physician specified limit , total procedure contrast volume saved (mL), and % contrast saved
Standardized hydration protocolOther
hydration protocol based up on the Poseidon protocol
| Study group | Role | What they receive |
|---|---|---|
| Standardized Hydration protocol | Active comparator | These cases will follow Charleston Area Medical Centers standard Hydration protocol Receives: Other: Standardized hydration protocol |
| Hydration + Device | Active comparator | These cases will follow Charleston Area Medical Centers standard hydration protocol plus use the DyeVert Plus System Receives: Device: DyeVert Plus System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of AKI
Determined by GFR levels
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start3 Feb 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion3 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI (Acute Kidney Injury) Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Design: This is a prospective randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 1,802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aravinda Nanjundappa, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279457
- Sponsor's protocol ID
- 19-637
- Acronym
- Dye-Vert Plus
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System
- ClinicalTrials.gov ID
- NCT04279457
- Acronym / sponsor ID
- Dye-Vert Plus / 19-637
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,802 participants (estimated)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 3 Feb 2022 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures which require the use of intravenous contrast media. The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar contrast media, repeated exposure to contrast within 48 hours, volume of contrast used). Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of low-osmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. The DyeVert plus Contrast Reduction System, is designed to lower the amount of contrast dye the kidneys are exposed to during a procedure. Because the amount of contrast dye is precisely controlled. The purpose of this prospective study is to understand how the monitoring system of Dye-Vert Plus will impact Acute Kidney Injuries rates in high-risk patients undergoing cardiac catheterization when used in conjunction with a standardized hydration policy.
Detailed description
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures associated with Contrast-induced nephropathy (CIN). The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%1. The development of CIN after diagnostic coronary angiography and/or percutaneous coronary intervention (PCI) is associated with prolonged hospitalization and a remarkable increase in morbidity, early and late mortality and costs. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar CM, repeated exposure to contrast within 48 h, volume of contrast used, etc.)2-5. Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of lowosmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. Patients that have a serum creatinine of > 1.5mg/dl and an eGFR < 60ml/min might be at higher risk for AKIs. In quarter one of 2018, CAMC's in-hospital risk-adjusted acute kidney injury for patients undergoing PCI was 10.64, and the US 50th percentile was 6.476. The goal of this study is to reduce in-hospital risk-adjusted acute kidney injury for patients undergoing PCI, below the US 50th, percentile-based NCDR quarterly results of the Cath-PCI registry by quarter one of 2020.
CIN is one of the leading causes of acute kidney injury at Charleston Area Medical Center it is imperative to take steps to prevent it. CIN is associated with a 13% increase in one- year mortality rate when comparing patients without CIN. Studies have also shown an increase in inpatient length of stay and substantial increase cost for patients who experienced CIN. The economic burden associated with CIN is high, the average in-hospital cost of CIN is $10,345 7. Adopting targeted interventions will reduce the incidence of CIN and the overall economic burden at Charleston Area Medical Center.
This trial is aimed at observing whether the use of the monitoring system Dye-Vert PLUS in conjugation with implementing a pre-hydration protocol on patients with high risk for CIN admitted for cardiac angiography and/or interventional cath lab procedures may reduce the incidence of CIN. An additional aim of the study will be to assess if use of the Dye-Vert PLUS monitoring system reduces the use of mean contrast media given in high-risk patients. Additional aims of this initiative will be to evaluate contrast-related complications, such as hypersensitivity reactions, as well as the associated impact of contrast-related complications on hospital health 3 care economics. This initiative will strive to incorporate clinical practice guidelines from SCAI Expert Consensus Statement: 2016 Best Practices in the Cardiac Catheterization Laboratory related to patient risk screening, pre-procedure hydration, and minimizing contrast media dose used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Design: This is a prospective randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standardized Hydration protocol | Active comparator | Other: Standardized hydration protocolThese cases will follow Charleston Area Medical Centers standard Hydration protocol |
| Hydration + Device | Active comparator | Device: DyeVert Plus SystemThese cases will follow Charleston Area Medical Centers standard hydration protocol plus use the DyeVert Plus System |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DyeVert Plus SystemThe DyeVert Plus System also contains a reusable Contrast Monitoring Wireless Display (CMW) which communicates with the Dye-Vert Plus Disposable to allow real-time monitoring and display of contrast volumes manually injected compared to a predefined, physician-entered contrast usage threshold throughout the procedure. At the end of the procedure, the CMW displays total procedure contrast volume used (mL), % of physician specified limit , total procedure contrast volume saved (mL), and % contrast saved | Device | Hydration + Device |
| Standardized hydration protocolhydration protocol based up on the Poseidon protocol | Other | Standardized Hydration protocol |
Primary outcome
Monitoring of AKI
Time frame: 3 days
Determined by GFR levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DyeVert Plus System and Standardized hydration protocol in people with AKI (Acute Kidney Injury) Due to Trauma, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank H Annie, PhD (304-388-9921, frank.h.annie@camc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring of AKI (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.